Rowan Schouten, Peter Lewkonia, Vanessa K. Noonan, Marcel F. Dvorak and Charles G. Fisher
The aim of this study was to define the expected functional and health-related quality of life outcomes following common thoracolumbar injuries on the basis of consensus expert opinion and the best available literature. Patient expectations are primarily determined by the information provided by health care professionals, and these expectations have been shown to influence outcome in various medical and surgical conditions. This paper presents Part 2 of a multiphase study designed to investigate the impact of patient expectations on outcomes following spinal injury. Part 1 demonstrated substantial variability in the information surgeons are communicating to patients. Defining the expected outcomes following thoracolumbar injury would allow further analysis of this relationship and enable surgeons to more accurately and consistently inform patients.
Expert opinion was assembled by distributing questionnaires comprising 4 cases representative of common thoracolumbar injuries to members of the Spine Trauma Study Group (STSG). The 4 cases included a thoracolumbar junction burst fracture treated nonoperatively or with posterior transpedicular instrumentation, a low lumbar (L-4) burst fracture treated nonoperatively, and a thoracolumbar junction flexion-distraction injury managed with posterior fusion. For each case, 5 questions about expected outcomes were posed. The questions related to the proportion of patients who are pain free, the proportion who have regained full range of motion, and the patients' recreational activity restrictions and personal care and social life limitations, all at 1 year following injury, as well as the timing of return to work and length of hospital stay. Responses were analyzed and combined with the results of a systematic literature review on the same injuries to define the expected outcomes.
The literature review identified 38 appropriate studies that met the preset inclusion criteria. Published data were available for all injuries, but not all outcomes were available for each type of injury. The survey was completed by 31 (57%) of 53 surgeons representing 24 trauma centers across North America (15), Europe (5), India (1), Mexico (1), Japan (1) and Israel (1). Consensus expert opinion supplemented the available literature and was used exclusively when published data were lacking.
For example, 1 year following cast or brace treatment of a thoracolumbar burst fracture, the expected outcomes include a 40% chance of being pain free, a 70% chance of regaining pre-injury range of motion, and an expected ability to participate in high-impact exercise and contact sport with no or minimal limitation. Consensus expert opinion predicts reemployment within 4–6 months. The length of inpatient stay averages 4–5 days.
This synthesis of the best available literature and consensus opinion of surgeons with extensive clinical experience in spine trauma reflects the optimal methodology for determining functional prognosis after thoracolumbar trauma. By providing consistent, accurate information surgeons will help patients develop realistic expectations and potentially optimize outcomes.
Charles G. Fisher, Christian P. DiPaola, Vanessa K. Noonan, Christopher Bailey and Marcel F. S. Dvorak
The nature of physician-industry conflict of interest (COI) has become a source of considerable concern, but is often not discussed in the research setting. With reduced funding available from government and nonprofit sources, industry support has enthusiastically grown, but along with this comes the potential for COI that must be regulated. In this era of shared decision making in health care, society must have input into this regulation. The purpose of this study was to assess the opinions of a North American population sample on COI regarding industry-funded research and to analyze population subgroups for trends.
A survey was developed for face and content validity, underwent focus group evaluation for clarity and bias reduction, and was administered via the World Wide Web. Demographic and general survey results were summarized as a percentage for each answer, and subgroup analysis was done using logistic regression. Generalizability of the sample to the US population was also assessed.
Of 541 surveys, 40 were excluded due to missing information, leaving 501 surveys for analysis. The sample population was composed of more females, was older, and was more educated than a representative cross-section of the American population. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies the most to head this effort. Respondents trust government officials and company representatives the least with respect to regulation of COI. Most respondents feel that industry-sponsored research can involve physicians and be both objective and beneficial to patients.
Most respondents in this study felt that surgeons should be involved in industry-sponsored research and that more research, regardless of funding source, will ultimately benefit patients. The majority of respondents distrust government or industry to regulate COI. The development of evidence-based treatment recommendations requires the inclusion of patient preference. The authors encourage regulatory bodies to follow suit and include society's perspective on regulation of COI in research.
Jin W. Tee, Carly S. Rivers, Nader Fallah, Vanessa K. Noonan, Brian K. Kwon, Charles G. Fisher, John T. Street, Tamir Ailon, Nicolas Dea, Scott Paquette and Marcel F. Dvorak
The aim of this study was to use decision tree modeling to identify optimal stratification groups considering both the neurological impairment and spinal column injury and to investigate the change in motor score as an example of a practical application. Inherent heterogeneity in spinal cord injury (SCI) introduces variation in natural recovery, compromising the ability to identify true treatment effects in clinical research. Optimized stratification factors to create homogeneous groups of participants would improve accurate identification of true treatment effects.
The analysis cohort consisted of patients with acute traumatic SCI registered in the Vancouver Rick Hansen Spinal Cord Injury Registry (RHSCIR) between 2004 and 2014. Severity of neurological injury (American Spinal Injury Association Impairment Scale [AIS grades A–D]), level of injury (cervical, thoracic), and total motor score (TMS) were assessed using the International Standards for Neurological Classification of Spinal Cord Injury examination; morphological injury to the spinal column assessed using the AOSpine classification (AOSC types A–C, C most severe) and age were also included. Decision trees were used to determine the most homogeneous groupings of participants based on TMS at admission and discharge from in-hospital care.
The analysis cohort included 806 participants; 79.3% were male, and the mean age was 46.7 ± 19.9 years. Distribution of severity of neurological injury at admission was AIS grade A in 40.0% of patients, grade B in 11.3%, grade C in 18.9%, and grade D in 29.9%. The level of injury was cervical in 68.7% of patients and thoracolumbar in 31.3%. An AOSC type A injury was found in 33.1% of patients, type B in 25.6%, and type C in 37.8%. Decision tree analysis identified 6 optimal stratification groups for assessing TMS: 1) AOSC type A or B, cervical injury, and age ≤ 32 years; 2) AOSC type A or B, cervical injury, and age > 32–53 years; 3) AOSC type A or B, cervical injury, and age > 53 years; 4) AOSC type A or B and thoracic injury; 5) AOSC type C and cervical injury; and 6) AOSC type C and thoracic injury.
Appropriate stratification factors are fundamental to accurately identify treatment effects. Inclusion of AOSC type improves stratification, and use of the 6 stratification groups could minimize confounding effects of variable neurological recovery so that effective treatments can be identified.
Brian K. Kwon, Charles G. Fisher, Michael C. Boyd, John Cobb, Hilary Jebson, Vanessa Noonan, Peter Wing and Marcel F. Dvorak
Unilateral facet injuries can be treated with either anterior or posterior fixation techniques with reportedly good outcomes. The two approaches have not been directly compared, however, and consensus is lacking as to which is the optimal method. The primary objective of this study was to determine whether acute postoperative morbidity differed between anteriorly and posteriorly treated patients with unilateral facet injuries.
Forty-two patients were prospectively randomized to undergo either anterior cervical discectomy and fusion or posterior fixation. The primary outcome measure was the postoperative time required to achieve a predefined set of discharge criteria. Secondary outcome measures included postoperative pain, wound infections, radiographically demonstrated fusion and alignment, and patient-reported outcome measures.
The median time to achieve the discharge criteria was 2.75 and 3.5 days for anterior and posterior groups, respectively, a difference that did not reach statistical significance (p = 0.096). Compared with those treated using posterior fixation, anteriorly treated patients exhibited somewhat less postoperative pain, a lower rate of wound infection, a higher rate of radiographically demonstrated union, and better radiographically proven alignment. Nonetheless, the anterior approach was accompanied by a risk of swallowing difficulty in the early postoperative period. Patient-reported outcome measures did not reveal a difference between anterior and posterior fixation procedures.
This prospective randomized controlled trial provided level 1 evidence that both the anterior and posterior fixation approaches appear to be valid treatment options. Although statistical significance was not reached in the primary outcome measure, some secondary outcome measures favored anterior fixation and others favored posterior treatment for unilateral facet injuries.